BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 3951137 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04308
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED THAT THE CRIMPED STENT HAD DETACHED FROM THE BALLOON AND WAS FREE MOVING ALONG THE SHAFT. THE STENT DID NOT APPEAR TO HAVE BEEN DEPLOYED. THERE WAS NO VISIBLE DAMAGE NOTED WITH ANY OF THE STENT STRUTS. AN EXAMINATION OF THE BALLOON IDENTIFIED A CLEAR IMPRESSION OF THE INITIAL STENT CRIMP ON THE BALLOON MATERIAL. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO ANY POSITIVE PRESSURE AND AS A RESULT THE BALLOON WAS TIGHTLY FOLDED AROUND THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVEMENT ON A BALLOON OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED SUBCLAVIAN ARTERY. THE LENGTH OF THE LESION WAS 38MM AND THE DIAMETER WAS 7MM. AFTER UNPACKING THE 7.0X40X135 CM EXPRESS¿ LD VASCULAR STENT, THEY NOTICED THE STENT WAS NOT AT THE MIDDLE PART OF THE BALLOON. THEY EXCHANGED THE DEVICE FOR ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT MOVEMENT ON A BALLOON OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED SUBCLAVIAN ARTERY. THE LENGTH OF THE LESION WAS 38MM AND THE DIAMETER WAS 7MM. AFTER UNPACKING THE 7.0X40X135 CM EXPRESS LD VASCULAR STENT, THEY NOTICED THE STENT WAS NOT AT THE MIDDLE PART OF THE BALLOON. THEY EXCHANGED THE DEVICE FOR ANOTHER OF THE SAME DEVICE AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427982 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162740130 15554022

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR